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6-K 1 ea0225316-6k_lakeshore.htm REPORT OF FOREIGN PRIVATE ISSUER

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

FORM 6-K

 

 

 

REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 UNDER
THE SECURITIES EXCHANGE ACT OF 1934

 

For the month of December 2024

 

Commission file number: 001-41598

 

 

 

LAKESHORE BIOPHARMA CO., LTD

(Exact name of registrant as specified in its charter)

 

 

 

Building No. 2, 38 Yongda Road

Daxing Biomedical Industry Park

Daxing District, Beijing, PRC

Tel: 010-89202086

(Address of Principal Executive Offices)

 

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F ☒     Form 40-F ☐

 

 

 

 


 

INCORPORATION BY REFERENCE

 

This current report on Form 6-K, including Exhibit 99.1 hereto, shall be deemed to be incorporated by reference into LakeShore Biopharma Co., Ltd’s registration statements on Form S-8 (File No. 333-279544 and File No. 333-273165) and to be a part thereof from the date on which this current report is furnished, to the extent not superseded by documents or reports subsequently filed or furnished.

 

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EXHIBITS

 

Exhibit No.   Description
99.1   Press Release – LakeShore Biopharma Reports Unaudited Financial Results for the First Half of Fiscal Year 2025 and Updates Full-Year Guidance

 

2


 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

LakeShore Biopharma Co., Ltd

   
  By: /s/ Rachel Yu
  Name:  Rachel Yu
  Title: Director and Chief Financial Officer

 

Date: December 19, 2024

 

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EX-99.1 2 ea022531601ex99-1_lakeshore.htm PRESS RELEASE - LAKESHORE BIOPHARMA REPORTS UNAUDITED FINANCIAL RESULTS FOR THE FIRST HALF OF FISCAL YEAR 2025 AND UPDATES FULL-YEAR GUIDANCE

Exhibit 99.1

 

LakeShore Biopharma Reports Unaudited Financial Results for the First Half of Fiscal Year 2025 and Updates Full-Year Guidance

 

² Achieved total revenue of RMB 371.9 million, reflecting a growth of 36.2% YoY

 

² Achieved gross profit of RMB 307.3 million, a growth of 39.1% YoY

 

² Gross margin increased to 82.6% from 80.9% in the same period of FY2024
   
² Total operating expenses decreased to RMB 276.4 million, down 31.6% YoY

 

² Recorded net income of RMB 20.6 million, and adjusted net income1 (Non-GAAP) of RMB 30.4 million, compared to net loss and adjusted net loss1 (Non-GAAP) of RMB 174.5 million in the same period of FY2024

 

LakeShore Biopharma Co., Ltd. (Nasdaq: LSB) (“LakeShore” or the “Company”), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer, today announced its financial results for the first six months ended September 30, 2024 (“FY2025H1”).

 

“We are thrilled with the outstanding financial performance achieved in the first half of FY2025 under the leadership of our new management team,” said Xu Wang, Chief Executive Officer. “Despite the challenging macroeconomic conditions in China, heightened competition, and the disruptive attempts against our company by former Chairman Yi Zhang, we have made a historical leap by achieving a net income of RMB 20.6 million - the first time we recorded net income since 2013. Moreover, we believe our revenue growth in the first half of FY2025 far outpaced most vaccine companies in China during the same period.”

 

Mr. Wang continued, “Our financial turnaround is a testament to our successful strategies to enhance operational efficiency and profitability, coupled with our effective execution on cost reduction, organizational restructuring, internal control improvement, optimized resource allocation, and enhanced cash flow management. Looking ahead, we remain committed to our corporate strategy, which aims to maximize value from our existing product portfolio and drive new business development, positioning us for a robust financial performance in FY2025 and beyond, thereby safeguarding and enhancing value for our shareholders.”

 

Business Update

 

YSJA Rabies Vaccine Phase III Clinical Trial Approval for Simplified Regimen

 

On October 25, 2024, the Company received approval from the National Medical Products Administration (NMPA) in China to conduct a phase III clinical trial evaluating the immunogenicity and safety of a simplified four-dose regimen for its YSJA rabies vaccine. The trial, scheduled to commence in late December 2024, will enroll 2,380 participants and compare the immunogenicity and safety of the YSJA rabies vaccine across two distinct four-dose immunization schedules against the existing Essen regimen (1-1-1-1-1). This randomized, double-blind, controlled study is expected to conclude by the third quarter of 2025.

 

 

1 Adjusted net income (loss) is a non-GAAP financial measure, which is defined as net income (loss) excluding share-based compensation expenses and loss on disposal of property, plant and equipment. See “Use of Non-GAAP Financial Measures” below.

 

 


 

The study aims to strengthen the competitiveness of the YSJA rabies vaccine in the rapidly growing rabies vaccine market, demonstrate its clinical superiority, and garner broader recognition and support from hospitals, academic institutions, and industry stakeholders in China and globally.

 

First Half of Fiscal Year 2025 Financial Results

 

Total Revenues

 

Total revenues reached RMB 371.9 million, compared to RMB 273.1 million in the same period of FY2024, representing a year-over-year growth of 36.2%. This increase was primarily driven by higher sales volume, attributable to increased batch approvals and doses available for sale, as well as the targeted and effective marketing initiatives.

 

Gross Profit

 

Gross profit was RMB 307.3 million, with a gross margin of 82.6%, compared to RMB 220.9 million and an 80.9% gross margin in the same period of FY2024. The improvement in gross margin was primarily driven by a reduction in unit production cost.

 

Selling and Marketing Expenses

 

Selling and marketing expenses totaled RMB 137.1 million, compared to RMB 157.7 million in the same period of FY2024, reflecting a 13.1% decrease. This reduction was attributed to cost reduction initiatives during the first half of FY2025.

 

General and Administrative Expenses

 

General and administrative expenses were RMB 70.8 million, up from RMB 67.6 million in the same period of FY2024. The increase was mainly driven by costs associated with workforce reduction.

 

Research and Development Expenses

 

Research and development expenses were RMB 68.5 million, compared to RMB 178.9 million in the same period of FY2024, representing a 61.7% decrease. This decline was primarily driven by reductions in testing fees, clinical trial fees, and consulting service fees following the conclusion of the Covid-19 vaccine clinical study.

 

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EBITDA and Adjusted EBITDA

 

EBITDA2 (Non-GAAP) and Adjusted EBITDA3 (Non-GAAP) was RMB 53.8 million and RMB 57.9 million, compared to negative EBITDA of RMB 138.6 million and negative adjusted EBITDA of RMB 159.5 million (Non-GAAP) respectively, in the same period of FY2024.

 

Operating Income

 

Operating income was RMB 30.9 million, compared to an operating loss of RMB 183.3 million in the same period of FY2024.

 

Net Income and Adjusted Net Income

 

Net income was RMB 20.6 million, and adjusted net income (Non-GAAP) was RMB 30.4 million, in contrast to net loss of RMB 174.5 million and adjusted net loss (Non-GAAP) of RMB 174.5 million, respectively, in the same period of FY2024.

 

Balance Sheet

 

As of September 30, 2024, the Company had cash and cash equivalents of RMB 112.5 million, compared to RMB 246.6 million as of March 31, 2024.

 

FY2025 Guidance Update

 

For the full FY2025, the Company expects total revenues to be between RMB 665 million and RMB 700 million, indicating a growth of 16% to 22% year-over-year. The Company also projects Adjusted EBITDA to range between RMB 76 million and RMB 89 million. These projections reflect the Company’s positive outlook for the current fiscal year, which would establish significant foundation for fiscal year 2026.

 

The above outlook is based on information available as of the date of this press release and reflects the Company’s current and preliminary views regarding its business situation and market conditions, which are subject to change.

 

About LakeShore Biopharma

 

LakeShore Biopharma, previously known as YS Biopharma, is a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer. It has developed a proprietary PIKA® immunemodulating technology platform and a new generation of preventive and therapeutic biologics targeting Rabies, Coronavirus, Hepatitis B, Influenza, Shingles, and other virus infections. The Company operates in China, the United States, Singapore, and the Philippines, and is led by a management team that combines rich local expertise and global experience in the biopharmaceutical industry. For more information, please visit investor.lakeshorebio.com.

 

 

  2 EBITDA is a non-GAAP financial measure, which is defined as net income (loss) before income tax expense (benefit), financial expenses - net and depreciation and amortization. See “Use of Non-GAAP Financial Measures” below.
3 Adjusted EBITDA is a non-GAAP financial measure, which is defined as net income/(loss) before income tax expense (benefit), financial expenses - net, and depreciation and amortization (“EBITDA”) adjusted to exclude share-based compensation expenses, late fees related to social security insurance, other income (expense) - net, fair value changes of warrant liability, and government grants. See “Use of Non-GAAP Financial Measures” below.

 

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Use of Non-GAAP Financial Measures

 

In evaluating the business, the Company considers and uses certain non-GAAP measures, including Adjusted EBITDA and adjusted net income (loss), as supplemental measures to review and assess its operating performance. The presentation of the non-GAAP financial measure is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with U.S. GAAP. The Company defines EBITDA as net income (loss) before income tax expense (benefit), financial expenses - net and depreciation and amortization. The Company defines Adjusted EBITDA as net income (loss) before income tax expense (benefit), financial expenses - net, and depreciation and amortization (“EBITDA”) adjusted to exclude share-based compensation expenses, late fees related to social security insurance, other income (expense) - net, fair value changes of warrant liability, and government grants. The Company defines adjusted net income (loss) as net income (loss) excluding share-based compensation expenses and loss on disposal of property, plant and equipment. The Company presents the non-GAAP financial measures because they are used by the management to evaluate the operating performance and formulate business plans. The Company also believes that the use of the non-GAAP measures facilitates investors’ assessment of its operating performance as this measure excludes certain finance or non-cash items that the Company does not believe directly reflect its core operations. The Company believes that excluding these items enables us to evaluate our performance period-over-period more effectively and relative to our competitors.

 

The non-GAAP financial measures are not defined under U.S. GAAP and are not presented in accordance with U.S. GAAP. The non-GAAP financial measures have limitations as analytical tools. One of the key limitations of using Adjusted EBITDA is that it does not reflect all items of income and expenses that affect the Company’s operations. Share-based compensation and loss on disposal of property, plant and equipment have been and may continue to be incurred in the business. Further, the non-GAAP measures may differ from the non-GAAP information used by other companies, including peer companies, and therefore their comparability may be limited.

 

The Company compensates for these limitations by reconciling the non-GAAP financial measure to the nearest U.S. GAAP performance measure, all of which should be considered when evaluating the Company’s performance. The Company encourages you to review its financial information in its entirety and not rely on a single financial measure.

 

Reconciliations of LakeShore Biopharma’s non-GAAP financial measures to the most comparable U.S. GAAP measure are included at the end of this press release.

 

Exchange Rate Information

 

This announcement contains translations of certain RMB amounts into U.S. dollars at a specified rate solely for the convenience of the reader. Unless otherwise noted, all translations from RMB to U.S. dollars are made at a rate of 7.0074 RMB to 1.00 USD, the exchange rate set forth in the central parity rate release of the People’s Bank of China on September 30, 2024.

 

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Cautionary Statement Regarding Forward-Looking Statements

 

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical or current fact included in this press release are forward-looking statements, including but not limited to statements regarding the expected growth of LakeShore Biopharma, the development progress of all product candidates, the progress and results of all clinical trials, LakeShore Biopharma’s ability to source and retain talent, and the cash position of LakeShore Biopharma. Forward-looking statements may be identified by the use of words such as “estimate,” “plan,” “project,” “forecast,” “intend,” “will,” “expect,” “anticipate,” “believe,” “seek,” “target” or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These statements are based on various assumptions, whether identified in this press release, and on the current expectations of LakeShore Biopharma’s management and are not predictions of actual performance.

 

LakeShore Biopharma cannot assure you the forward-looking statements in this press release will be accurate. These forward-looking statements are subject to a number of risks and uncertainties, including those included under the heading “Risk Factors” in the Company’s Annual Report on Form 20-F filed with the Securities and Exchange Commission (the “SEC”), and other risks described in documents subsequently filed or furnished by the Company from time to time with the SEC. There may be additional risks that LakeShore Biopharma does not presently know or that LakeShore Biopharma currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In light of the significant uncertainties in these forward-looking statements, nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. The forward-looking statements in this press release represent the views of LakeShore Biopharma as of the date of this press release. Subsequent events and developments may cause those views to change. However, while LakeShore Biopharma may update these forward-looking statements in the future, there is no current intention to do so, except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing the views of LakeShore Biopharma as of any date subsequent to the date of this press release. Except as may be required by law, LakeShore Biopharma does not undertake any duty to update these forward-looking statements.

 

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Lakeshore Biopharma Co., Ltd

UNAUDITED CONSOLIDATED BALANCE SHEETS

(All amounts in thousands, except for share and per share data)

 

    As of
March 31,
    As of September 30,  
    2024     2024     2024  
    RMB     RMB     US$  
                   
ASSETS                  
Current assets                  
Cash     246,351       49,466       7,059  
Restricted cash     200       63,069       9,000  
Accounts receivable - net     444,161       529,504       75,564  
Advance to suppliers - net     1,663       3,719       531  
Inventories - net     203,423       198,564       28,336  
Prepaid expenses and other current assets     7,370       8,013       1,144  
Total current assets     903,168       852,335       121,634  
                         
Non-current assets                        
Property, plant and equipment - net     473,348       447,410       63,848  
Operating lease right-of-use assets - net     7,275       2,513       359  
Deferred tax assets - net     23,634       22,416       3,199  
Intangible assets - net     71,245       68,149       9,725  
Other non-current assets     34,357       39,800       5,680  
Total non-current assets     609,859       580,288       82,811  
Total assets     1,513,027       1,432,623       204,445  
                         
LIABILITIES AND SHAREHOLDERS’ EQUITY                        
Current liabilities                        
Bank loans and other borrowings     318,541       288,288       41,141  
Accounts payable     67,775       46,878       6,690  
Accrued expenses and other liabilities     408,737       391,905       55,926  
Operating lease liabilities     5,157       1,406       201  
Deferred government grants     2,016       1,596       228  
Total current liabilities     802,226       730,073       104,186  
                         
Non-current liabilities                        
Bank loans and other borrowings     98,984       78,633       11,221  
Operating lease liabilities     1,784       259       37  
Deferred government grants     20,280       16,936       2,417  
Warrants liability     4,548       4,179       596  
Total non-current liabilities     125,596       100,007       14,271  
Total liabilities     927,822       830,080       118,457  
                         
Shareholders’ equity                        
Ordinary shares, par value US$0.00002 per share; 9,950,000,000 shares authorized; 190,227,959 and 190,807,516 shares issued and outstanding as of March 31, 2024 and September 30, 2024, respectively     26       26       4  
Additional paid-in capital     2,950,863       2,952,522       421,343  
Accumulated deficit     (2,307,504 )     (2,286,925 )     (326,358 )
Accumulated other comprehensive loss     (58,180 )     (63,080 )     (9,001 )
Total shareholders’ equity     585,205       602,543       85,988  
Total liabilities and shareholders’ equity     1,513,027       1,432,623       204,445  

 

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Lakeshore Biopharma Co., Ltd

UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(All amounts in thousands, except for share and per share data)

 

    Six Months Ended September 30,  
    2023     2024     2024  
    RMB     RMB     US$  
                   
Revenues     273,092       371,943       53,079  
Cost of revenues     52,187       64,681       9,230  
Gross profit     220,905       307,262       43,849  
                         
Operating expenses:                        
Selling and marketing     157,700       137,106       19,566  
General and administrative     67,611       70,807       10,105  
Research and development     178,853       68,491       9,774  
Total operating expenses     404,164       276,404       39,445  
                         
Income (loss) from operations     (183,259 )     30,858       4,404  
                         
Other income (expenses):                        
Late fees related to social security insurance     (446 )     (213 )     (30 )
Government grants     14,628       3,864       551  
Financial expenses - net     (12,968 )     (6,573 )     (938 )
Fair value changes of warrant liability     6,851       315       45  
Other income (expense) - net     (149 )     (6,454 )     (921 )
Total other income (expense) - net     7,916       (9,061 )     (1,293 )
                         
Income (loss) before income taxes     (175,343 )     21,797       3,111  
Income tax benefit (expense)     820       (1,218 )     (174 )
                         
Net income (loss)     (174,523 )     20,579       2,937  
                         
Net income (loss) attributable to Lakeshore Group     (174,523 )     20,579       2,937  
                         
Net income (loss)     (174,523 )     20,579       2,937  
Other comprehensive income (loss):                        
Foreign currency translation adjustment     3,166       (4,900 )     (700 )
Total comprehensive income (loss)     (171,357 )     15,679       2,237  
                         
Earnings (loss) per share:                        
– Basic and Diluted     (1.88 )     0.11       0.02  
Weighted average number of ordinary shares outstanding:                        
– Basic and Diluted     93,058,197       190,429,732       190,429,732  

 

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Lakeshore Biopharma Co., Ltd

Unaudited Reconciliations of Non-GAAP Results

(All amounts in thousands)

 

    Six Months Ended September 30,  
    2023     2024     2024  
    RMB     RMB     US$  
                   
Net income (loss)     (174,523 )     20,579       2,937  
Add: income tax expense (benefit)     (820 )     1,218       174  
Add: financial expenses - net     12,968       6,573       938  
Add: depreciation and amortization     23,734       25,414       3,627  
EBITDA     (138,641 )     53,784       7,676  
                         
Add: Share-based compensation expenses     -       1,659       237  
Add: late fees related to social security insurance     446       213       30  
Add: other income (expense) - net     149       6,454       921  
Add: fair value changes of warrant liability     (6,851 )     (315 )     (45 )
Add: government grants     (14,628 )     (3,864 )     (551 )
Adjusted EBITDA     (159,525 )     57,931       8,268  

 

    Six Months Ended September 30,  
    2023     2024     2024  
    RMB     RMB     US$  
                   
Net income (loss)     (174,523 )     20,579       2,937  
Add: share-based compensation expenses     -       1,659       237  
Add: loss on disposal of property, plant and equipment     -       8,210       1,172  
Adjusted net income (loss)     (174,523 )     30,448       4,346  

 

 

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